DTC expected to propel Afrezza awareness, not necessarily sales

MannKind CFO Matthew Pfeffer still believes that inhaled insulin Afrezza will be a blockbuster therapy despite a lackluster product launch.

"There are a lot of problems with current insulin therapies," Pfeffer said. "There's a need for a new therapy and we think we have it."

He predicted an uptick in prescriptions will occur when the DTC advertising campaign rolls out this summer and more physicians become aware of the product.

Pfeffer told investors on Wednesday at the Jefferies Global Healthcare Conference in New York City that broader efforts by Sanofi, MannKind's commercial partner for Afrezza, to raise awareness about Afrezza with physicians are already under way.

This includes delivering 54,000 sample packs to physicians, establishing a doctor-education seminar series and incorporating Afrezza into Sanofi's Coach, a free diabetes-management program also available to patients with prescriptions for Toujeo, a new basal insulin developed by Sanofi.

The DTC advertising campaign is expected to launch in the beginning of MannKind's third quarter, which begins on July 1. It was developed by Havas Health.

“While the scope of the DTC ads looks to be initially limited to print publications, largely in diabetes-specific periodicals, we expect this targeted advertising to have a considerable impact on raising both patient and physician awareness,” Jefferies analyst Shaunak Deepak wrote in a note this week.

The FDA last year approved Afrezza, making it the only inhaled insulin product available in the US. The meal-time insulin is considered a new option for patients who are resistant to using needles to inject insulin as well as the 3.1-million diabetes patients who are hesitant to begin treatment.

“I have no doubt this is going to be the blockbuster product we thought it would be,” Pfeffer said.

During the Jefferies presentation, Pfeffer acknowledged the slow launch and reports of hurdles faced by some patients to get a prescription for the therapy. Diabetes patients who are interested in Afrezza as a treatment option have to undergo lung tests prior to starting therapy as well as during the course of treatment.

Another issue is insurance reimbursement. About 20% of insurers do not provide any reimbursement for Afrezza, and the health insurers that do cover the therapy listed it with Tier 3 restrictions, which require a higher co-pay for the patient than Tier 1 and 2 treatments.

“Other meal-time insulin choices are available for people with diabetes without FDA black box warnings and with fewer risks of side effects,” a spokeswoman for Anthem, one of the nation's largest insurers, told MM&M in May.

During another session at the Jefferies conference, Novo Nordisk executive Karsten Munk Knudsen downplayed Afrezza as a significant threat to its products, saying the product is not as easy to use as it seems and noting that patients who are already taking insulin are also already using injections. “It's rather unimpressive,” he said.